Kornimate/medical-research-clean huggingface dataset:
laparoscopic-guided tap block in patients undergoing gastric bypass

Conditions: Pain, Postoperative

Summary: a prospective randomized trial will be performed. patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (tap) block as part of multimodal analgesia (group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (group 2). postoperative pain will be assessed with a visual analogic scale 24h after surgery and morphine needs will be quantified.

a prospective randomized trial will be performed. patients undergoing laparoscopic roux-en-y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided tap block with 30 ml bupivacaine 0.5%, as part of multimodal analgesia (group 1), associated with postoperative intravenous analgesia (metamizol 2g/8h and acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (metamizol 2g/8h and acetaminophen 1g/8h) (group 2). postoperative pain will be assessed with a visual analogic scale 24 hours after surgery and morphine needs will be quantified.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>40 kg/m2 * bmi \>35 kg/m2 and obesity associated comorbidities * patients undergoing laparoscopic roux en y gastric bypass exclusion criteria: * patients undergoing other bariatric procedures, different than roux en y gastric bypass * patients undergoing open bariatric surgery
cognitive impairment and balance in elderly

Conditions: Mild Cognitive Impairment

Summary: one important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. the objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.

mild cognitive impairment is described as a transitional stage between normal ageing and dementia, and reflects the clinical situation where a person has memory complaints and objective evidence of cognitive impairment but no evidence of dementia. mild cognitive is important in older people and it is also important to evaluate its repercussion in balance.

Eligibility criteria:
inclusion criteria: * nursing home residents. exclusion criteria: * surgery on lower limbs. * traumatic damage on lower limbs. * severe cognitive impairment in order not to complete the assessment.

Keywords: elderly nursing homes mild cognitive impairment
ger-009-06-avx early therapy in multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this study is being done to increase awareness for early therapy with avonex for multiple sclerosis (ms) and the cognitive dysfunction that accompanies ms, and to record safety data for avonex.

this study will address the cognitive dysfunction associated with ms. it will track these changes and show that early intervention with avonex is effective in slowing ms and its effect on patients. safety data will also be collected during this study.

Eligibility criteria:
inclusion criteria: * cis (according to indication) or early relapsing remitting multiple sclerosis exclusion criteria: * treatment with dmt during the last 12 months

Keywords: multiple sclerosis cognitive dysfunction in multiple sclerosis early treatment avonex interferon beta 1a cognitive dysfunction
path study: people with injecting related infections: assessing treatment outcomes for those who are hospitalised.

Conditions: Invasive Fungal Infections; Invasive Bacterial Infection; Injection Site Infection; Infection, Bacterial; Infection, Fungal; Infection, Soft Tissue

Summary: we seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.

this study will be conducted as a prospective, observational cohort study of adults admitted with invasive bacterial and fungal infectious diseases. this study will be conducted at multiple hospitals in australia. participants will be invited for screening whilst they are inpatients of the hospital. participants will be screened for history of injection drug use in the last 6 months and presence of an invasive bacterial or fungal infection. eligible participants will be treated through standard of care with the applicable treatment. all participants will commence antimicrobial treatment whilst they are inpatients. for participants who are discharged before planned treatment completion, a hospital discharge visit (early discharge electronic case report form \[ecrf\]) will be conducted. following the end of treatment, participants will be reviewed at 6, 12 and 48-weeks post-enrolment. at follow-up visits, behavioural surveys, health-related quality of life, and experiences with hospital care will be assessed. individual patient involvement will include four visits over a 12-month period. the duration of the study is anticipated to be 5 years.

Eligibility criteria:
inclusion criteria: 1. have voluntarily signed the informed consent form, 2. 18 years of age or older, 3. injected drugs within the last 6 months, 4. admitted to hospital with invasive bacterial or fungal infection, a. examples of invasive infection include: bloodstream infection, bone and joint infection (osteomyelitis, septic arthritis, discitis), central nervous system infection (epidural abscess, meningitis), deep abscess (i.e., brain, liver, muscle, spleen), endovascular infection (infective endocarditis, septic thrombophlebitis, mycotic aneurysm, septic embolism), skin or soft tissue infection (necrotising fasciitis, myositis), exclusion criteria: 1) is unable or unwilling to provide informed consent or abide by the requirements of the study.

Keywords: antimicrobial therapy patient-directed discharge injection-related infectious diseases
metabolic and neurofunctional responses to breakfasts

Conditions: Feeding Behaviors; Lack of Satiety; Attention Deficit and Disruptive Behavior Disorders

Summary: this study aims at assessing the effects of glucose and different types of breakfast on metabolic and neurofunctional responses in healthy individuals. twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either a 50 g glucose load (control) or one of these breakfast: b1: milk (125ml) and cereals (30g); b2: milk (220ml), apple (200g) and cream chocolate filled sponge cake (30g); b3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate (15g). prior and upon completion of each tolerance test, an eeg was performed to measure frontal p300-evoked potentials.


Eligibility criteria:
inclusion criteria: * bmi 18.5 - 24.9 kg/m2 * normal glucose tolerance * stable diet exclusion criteria: * type 1 and type 2 diabetes * impaired glucose tolerance * dyslipidemia * metabolic syndrome

Keywords: ghrelin breakfast meal p-300
an evaluation of patient reported outcomes and clinical outcomes

Conditions: Post-Operative Complications in Cardiac Surgery

Summary: this extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: * patient reported outcomes (pro), using the eq-5d questionnaire * clinical outcomes


Eligibility criteria:
inclusion criteria: * subjects must have completed the ren-007 study to be eligible to participate in the extension study. exclusion criteria: * subjects who did not complete the ren-007 study are not eligible to participate in the extension study. * female subjects who become pregnant during the ren-007 study are not eligible to participate in the extension study.
characterisation of gut microbiota, bispectral index data and plasma kynurenine in patients undergoing thyroid surgery

Conditions: Sleep Deprivation

Summary: the study is a case-controlled observational trial. forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night bispectral index data. firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

the study is a case-controlled observational trial. forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night bispectral index data. firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Eligibility criteria:
inclusion criteria: * ethnic chinese; * age, 18 to 65 years old; * american society of anaesthesiologists (asa) physical status i or ii exclusion criteria: * cognitive difficulties * affiliated with the social security system * partial or complete gastrectomy * previous esophageal surgery * inability to conform to the study's requirements * deprivation of a right to decide by an administrative or juridical entity * ongoing participation or participation in another study \<1 month ago
a study of hstc810 in combination with paclitaxel in relapsed or refractory extensive stage small cell lung cancer

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: the purpose of this clinical study is to assess the safety and efficacy of hstc810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.

the study will be conducted in 2 parts. phase ib will evaluate the safety of the combination of hstc810 with a standard dose of paclitaxel using a 3+3 dose escalation design. phase ii will evaluate the efficacy of hstc810 + paclitaxel combination therapy using a simon 2-stage method.

Eligibility criteria:
inclusion criteria: * ability to understand and sign an informed consent form * male or female ≥ 18 years of age * histologically or cytologically confirmed sclc * r/r es-sclc on or after platinum-based chemotherapy for sclc with documented disease progression * at least 1 measurable lesion as defined by recist 1.1 * eastern cooperative oncology group performance score (ecog ps) of 0 or 1 * life expectancy of at least 3 months * adequate organ function as described in the protocol * for female or male patients with reproductive potential: agree to use contraception throughout the study and at least 5 months after the last dose. exclusion criteria: * known active leptomeningeal disease (carcinomatous meningitis) * known active and uncontrolled central nervous system (cns) metastases * treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent \< 14 days prior to initiation of study treatment * treatment with radiation therapy \< 14 days prior to initiation of study treatment * major surgery \< 21 days prior to initiation of study treatment * received live vaccine \< 30 days prior to initiation of study treatment, including intranasal influenza vaccine * history of another primary malignancy with protocol-defined exceptions * active or history of autoimmune disease requiring systemic treatment * receiving high doses of steroids or other immunosuppressive medications * active hepatitis b or c infection * active or history of non-infectious pneumonitis requiring treatment with steroids * active uncontrolled viral, fungal, or bacterial infection including tuberculosis * pregnant or breastfeeding female patients * history of severe hypersensitivity reaction to a monoclonal antibody treatment * history of severe hypersensitivity reaction or ≥ grade 3 adverse event (ae) to paclitaxel treatment * history of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening * qt corrected for fridericia's method (qtcf) \> 470 ms at screening * lack of resolution of any toxicity to max grade 1 (except alopecia) * active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study * known psychiatric or substance use disorder * positive coronavirus disease 2019 (covid-19) test at screening
an observational study to determine the clinical cure rate of therapeutic up front shave removal of basal cell carcinoma of the skin with long term follow up to evaluate recurrence

Conditions: Basal Cell Carcinoma

Summary: determine the effectiveness of a deep shave removal as a definitive treatment for basal cell carcinoma (bcc) without the need for a follow up surgical procedure.

basal cell carcinoma (bcc) is the most common skin cancer in the world, with approximately 3.5 million cases a year diagnosed in the united states. bcc are indolent and metastasis is extremely rare, occurring in less than .003% of cases. however, due to the high prevalence of this tumor, significant health care resources are used in its diagnosis and treatment. management of bcc in many instances includes clinical evaluation of the lesion, biopsy or sampling of the lesion to confirm the diagnosis, followed by definitive treatment at a later date through surgical excision or medical therapy. a clinical diagnosis of bcc can be made with a high degree of confidence based on clinical findings. the investigators propose that by performing a deep shave removal of the entire lesion with histologically negative margins, based upon clinical diagnosis, complete removal can be achieved without the need for follow up therapy. deep shave removal at time of initial evaluation is performed in many instances. the investigators believe that doing a deep shave removal would substantially reduce the number of second procedures that need to be done, thereby reducing treatment costs and patients' need to return for an additional procedure. in doing a deep shave removal, clinically diagnosed bcc will be removed entirely with narrow 2-3 mm margins, the tissue specimen will then be sent to the pathologist to confirm that margins are clear. the investigators will consider treatment of the bcc to be complete at this point and will follow the patients clinically.

Eligibility criteria:
inclusion criteria: * patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a bcc, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles * subject is able to give informed consent * subject is able to commit to 6 month follow up visit exclusion criteria: * bcc \> 1cm in diameter on any one axis. * immunosuppressed patients * subjects with neutropenia * organ transplant patients * subjects with a life expectancy less than year * patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral tacrolimus, any tumor necrosis factor (tnf)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject * basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination * subjects unable to provide informed consent * subjects unable to commit to 6 month follow up
a study for post op inflammation after cataract surgery

Conditions: Cataract

Summary: this is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.

there will be approximately 40 eyes with two groups: group 1 (20 eyes) will receive treatment with topical 1% prednisolone acetate drops qid x 1 week, then dextenza will be inserted at the one-week postoperative evaluation (day 8). group 2 (20 eyes) will receive treatment with topical 1% prednisolone acetate for five weeks with dosing schedule: qid x 2 weeks, tid x 1 week, bid x 1 week, qd x 1 week. both groups will receive topical prolensa qa.m. x 5 weeks and moxifloxacin tid x 1 week, per investigators preferential treatment regimen. each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: baseline (screening visit day -1), operative visit (day 0), day 1, day 8 (insertion day), day 14, and day 37.

Eligibility criteria:
inclusion criteria: subjects will be eligible for study participation if they: 1. are planning to undergo non-complicated cci ce/pciol in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration. 2. are willing and able to comply with clinic visits and study related procedures 3. are willing and able to sign the informed consent form 4. patients age 18yo+ exclusion criteria: subjects are not eligible for study participation if they: 1. have active infectious systemic disease 2. have active infectious ocular or extraocular disease 3. have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis) 4. have known hypersensitivity to dexamethasone or are a known steroid responder 5. have a history of ocular inflammation or macular edema 6. are currently being treated with immunomodulating agents in the study eye(s) 7. are currently being treated with immunosuppressants and/or oral steroids 8. are currently being treated with corticosteroid implant (i.e. ozurdex) 9. have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye 10. have a history of complete punctal occlusion in one or both punctum 11. currently use topical ophthalmic steroid medications 12. are currently pregnant or nursing. 13. are unwilling or unable to comply with the study protocol 14. are determined by the investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
clinical application of breast blood-oxygen functional imaging technology

Conditions: Breast Diseases

Summary: this trial is going to evaluate the value of blood-oxygen functional imaging technology in the diagnosis of breast diseases.


Eligibility criteria:
inclusion criteria: * female older than 18 years breast lump received breast ultrasound and mammography exclusion criteria: * after core-needle biopsy or resection after neoadjuvant chemotherapy, radiotherapy or endocrine therapy

Keywords: blood-oxygen functional imaging technology diagnosis
effect of virtual reality-based therapy on negative symptoms in people with schizophrenia

Conditions: Schizophrenia

Summary: a randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a vr assisted treatment for negative symptoms in people with schizophrenia. patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of vr assisted therapy plus treatment as usual (tau). a control group will be exposed to a neutral vr environment plus tau. the hypothesis is that patients who are treated with active vr assisted therapy will have less negative symptoms as rated by the panss-n scale, compared to the control group. the protocol was approved by the hospital ethics committee of the servicio de salud metropolitano suroriente. patients sign an informed consent form, from which they may withdraw at any point during the intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under cie-10 criteria. * age between 18 to 65 years-old. * outpatient setting, * clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization. * no concomitant active substance abuse disorder, excluding nicotine. * subjects are capable of providing informed consent. exclusion criteria: * previous diagnosis of learning disability according either to icd- 10 or clinical history * verbal expression difficulties, determined by language or medical causes. * deafness and/or blindness. * other physical handicaps to use vr devices. * predominant positive symptoms, defined as panns-c \> 0. * catatonic symptoms. * previous epilepsy diagnosis. * neurodegenerative disease.

Keywords: schizophrenia virtual reality negative symptoms
effect of myoma removal on blood pressure and erythropoetin level

Conditions: Myoma; Hypertension

Summary: the effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

background: myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. early reports suggested the association of myoma and hypertension. we studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis. patients \& methods: in this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

Eligibility criteria:
inclusion criteria: * candidate for myoma removal by hysterectomy * operable * hysterectomy is indicated exclusion criteria: * patient refusal * inoperable patients * other secondary cases of hypertension

Keywords: myoma hypertension erythropoetin blood pressure erythropoetin level
acute hemostasis following the use of the aquabeam® system for the treatment of benign prostatic hyperplasia iii

Conditions: Benign Prostatic Hyperplasia

Summary: a dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the aquabeam system.

procept biorobotics has developed the aquabeam, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from luts due to bph. the primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents following prostate resection using aquabeam for the treatment of luts resulting from bph. up to 50 participants will be included in the trial at one clinical study site. all patients will be followed up for 3 months for safety assessment prior to study exit. the trial is a dual-arm prospective, interventional clinical trial.

Eligibility criteria:
inclusion criteria: * male * bph symptoms exclusion criteria: * serious concurrent medical conditions

Keywords: image-guided bph aquablation aquabeam luts tissue resection robotics